PMDA device listing

タイタン400

PMDA Medical device listing · 27B1X00040000152 · Class I

Key facts

PMDA document key 340912_27B1X00040000152_A_01
Brand names タイタン400
General names (JMDN) 汎用光源
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 27B1X00040000152
JMDN codes 32037000
Category code A0200
Marketing authorization holder 製造販売/株式会社ジェイエスエス
Package insert date Nov 30, 2020
PMDA product page pmda.go.jp
Package insert on pmda.go.jp pmda.go.jp

At a glance

  • 1–9 Package insert revisions
  • None Related PMDA documents
  • Listed Listed on the PMDA site
  • Yes Refers to a technical manual

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About PMDA medical device and IVD listings (Japan)

Medical devices and in vitro diagnostics sold in Japan are approved by the MHLW, certified by a registered certification body or notified, depending on class, and the PMDA publishes each product's package insert. Only identifiers, names and dates are shown here; package insert text and review reports are not reproduced.

Source: Pharmaceuticals and Medical Devices Agency (PMDA), Japan, medical device package insert database · Source date:

Browse all PMDA medical device and IVD listings (Japan)